Quick answers
- What is Tamoxifen citrate used for?
- The FDA-approved label (Soltamox, Mayne Pharma, November 29, 2021) says: “SOLTAMOX is an estrogen agonist/antagonist indicated: For treatment of adult patients with estrogen receptor-positive metastatic breast cancer For adjuvant treatment of adult patients with early stage estrogen receptor- positive breast cancer To reduce risk of invasive breast cancer following breast surgery and radiation in adult women with ductal carcinoma in situ (DCIS) To reduce the incidence of breast cancer in …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Tamoxifen citrate have a boxed warning?
- Yes. The FDA label for Soltamox has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Tamoxifen citrate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Tamoxifen citrate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Tamoxifen citrate?
- 10 companies list prescription products of Tamoxifen citrate in the FDA NDC Directory, including Bryant Ranch Prepack, Aurobindo Pharma Limited and NuCare Pharmaceuticals, Inc..
What Tamoxifen citrate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
SOLTAMOX is an estrogen agonist/antagonist indicated: For treatment of adult patients with estrogen receptor-positive metastatic breast cancer For adjuvant treatment of adult patients with early stage estrogen receptor- positive breast cancer To reduce risk of invasive breast cancer following breast surgery and radiation in adult women with ductal carcinoma in situ (DCIS) To reduce the incidence of breast cancer in …
— FDA label: Soltamox, Mayne Pharma, effective November 29, 2021. Read the full label on DailyMed →
The FDA has 14 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
14 of 14 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet · Tablet, film coated · Liquid |
|---|---|
| Route | Oral |
| Prescription products | 18 in the FDA NDC Directory |
| Brand names | Soltamox |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| tamoxifen citrate 10 mg tablet | Generic | $0.1321 per tablet |
| tamoxifen citrate 10 mg tablet, film coated | Generic | $0.1321 per tablet |
| tamoxifen citrate 20 mg tablet | Generic | $0.2747 per tablet |
| tamoxifen citrate 20 mg tablet, film coated | Generic | $0.2747 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack3 products
- Aurobindo Pharma Limited2 products
- NuCare Pharmaceuticals, Inc.2 products
- Mylan Pharmaceuticals Inc.2 products
- Actavis Pharma, Inc.2 products
- A-S Medication Solutions2 products
- Dr. Reddy's Labratories Inc.2 products
- Proficient Rx LP1 product
- Mayne Pharma Commercial LLC1 product
- Mayne Pharma1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021807 SOLTAMOX | Mayne Pharma Commrcl | October 29, 2005 | 4, latest April 8, 2019 2019: Labeling · 2018: Efficacy · 2015: Manufacturing (CMC) |
Generic approvals (4)
- ANDA070929Actavis Labs Fl Inc · February 20, 2003
- ANDA074732Mylan · February 20, 2003
- ANDA075797DR Reddys Labs SA · February 20, 2003
- ANDA213358Eugia Pharma · August 14, 2020
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 198240, 313195, 389230, 644304 |
|---|---|
| SPL set ID of the quoted label | 1e6ff055-590c-41e6-9530-1fdf04cdbd02 |
| FDA labels (SPL) | 14 |
| FDA applications | NDA021807, 4 ANDA |
| Active ingredients (FDA) | TAMOXIFEN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Soltamox, Mayne Pharma, effective November 29, 2021; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →